Regulatory Coordinator II
$80,172–$104,250 year
On-siteSeattle, Washington, United States
Job Summary
Prepare, track, and maintain all regulatory correspondence and documentation for the Infectious Disease Sciences Program, including drafting content for IRB, FDA, and sponsor submissions. Lead study start-ups by preparing documents for new applications and manage ongoing study maintenance through amendments and renewals. Conduct internal quality assurance audits, perform study close-outs, and archive records in compliance with FDA guidelines. Serve as the primary regulatory resource for PIs and study teams, resolving issues identified during monitoring visits and reporting non-compliance to the IRB. Coordinate regulatory documents for multi-site studies and track annual continuing reviews to prevent expirations. Submit documents to governing bodies and work with the fiscal team on funding proposals and progress reports.
Required Qualifications
- High school diploma or equivalent
- Minimum of two years of regulatory, human research protection or related experience in a research environment
- Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.)
- Knowledge of FDA, GCP and NIH requirements
- Ability to interpret and synthesize regulations and guidelines
- Ability to adapt and adjust priorities based on changing needs
- Strong written and verbal communication skills
- Problem solving skills
- Ability to reach and reconcile data in reports
- Ability to use discretion and maintain confidentiality
- Proficiency with MS Office suite
- Associate or Bachelor's degree
- Previous clinical research regulatory coordinator experience working within Fred Hutchinson Cancer Center, University of Washington, or Seattle Children's institutional regulatory system
- Previous experience working with online/web-based platforms for clinical trial management
- Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice
- Must be able to work partially at our campus and remotely
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